DESCRIPTION
id: 007c8f4b-72d8-4f6d-b4bf-57e0a74620f0
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Contains lidocaine HCl 3%. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:
C14H22N2O Mol.wt.234.34
Each gram of Lidocaine HCl 3% Lotion contains ACTIVE: Lidocaine HCl 30 mg in a lotion base of INACTIVES: Aluminum sulfate, calcium acetate, cetyl alcohol, glycerine, mineral oil, methyl paraben, white petrolatum, glyceryl monostearate SE, propyl paraben, purified water, sodium hydroxide, sorbitan stearate, stearic acid and stearyl alcohol
INDICATIONS
id: 58cd35ab-72d6-425b-924d-923cbf5c6154
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritus ani, pruritus vulvae, hemorrhoids, anal fissures, and similar conditions of the skin and mucous membranes.
CONTRAINDICATIONS
id: 041563e4-02d0-45d5-82ad-2c1cbfa2bf07
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Traumatized mucosa, secondary bacterial infection of the area of proposed application and known hypersensitivity to any of the components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
WARNINGS
id: 4354e8aa-0966-4a33-8177-4bb20379c7a5
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
For external use only. Not for ophthalmic use.
PRECAUTIONS
id: 9ddf448f-dd41-4272-8d1b-d837403d4d5a
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
If irritation or sensitivity occurs or infection appears, discontinue treatment and institute appropriate therapy. Lidocaine HCl 3% Lotion should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine.
ADVERSE REACTIONS
id: 85e7e9d3-186b-4c11-8673-4c6d0dc52694
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or maybe the locus of abnormal sensation.
DOSAGE AND ADMINISTRATION
id: 2ad1df3c-2284-45d2-8f94-0065c6ee529f
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Apply a thin film to the affected area two or three times daily or as directed by a physician.
HOW SUPPLIED
id: 64eee4d2-0267-4d6d-935d-f2e5be2ebae8
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lidocaine HCl 3% Lotion is supplied in the following size:
| Size |
NDC# |
| 6oz. (177 mL) Bottle |
58980-822-60 |
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
PRINCIPAL DISPLAY PANEL – 177 mL Bottle Carton
id: 1fc5787c-5cb5-462b-89ff-cd26f3098f54
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 58980-822-60
TOPICAL ANESTHETIC
LIDOCAINE
HCl 3% LOTION
Smooth
Easily Spreadable
Rx only
STRATUS
PHARMACEUTICALS INC
Net WT. 6 OZ (177 mL)
